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NeoplasmsMETHYLSCAPE-CONCT07741435

Methylation Profile Test (Methylscape) in Body Fluids for Multi-Cancer Detection and Monitoring in Colombia

An observational study of Neoplasms and Solid Tumor, run by Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo at 1 site in Colombia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

DNA methylation changes occur early and broadly during carcinogenesis. Methylscape is a rapid assay that detects global DNA methylation patterns in body fluids (blood, urine, and saliva) and may detect a cancer signal and predict the cancer signal origin (CSO) from a single fluid sample, using the differential… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Neoplasms, Solid Tumor, Breast Neoplasms
What is being tested?
Methylscape DNA methylation assay
How many people
3,250 participants
Where
1 siteColombia
Study dates
5 Jun 2025to 15 Jan 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Colombian adults (≥18 years) with biopsy-confirmed solid tumors selected by local incidence (emphasis on breast, lung, and gastric cancer) and age- and sex-matched cancer-free volunteers, recruited at a single cancer center (CTIC) in Bogotá, Colombia.

Who may be able to join

  • Adults aged 18 years or older.
  • Willing and able to participate and to provide the required samples (blood, urine, saliva) and demographic information (age, sex, race/ethnicity, BMI).
  • Able to provide written informed consent for participation and for use of biological samples. For CTIC Biobank samples, prior research-use consent is verified.
  • Demographic/anthropometric comparability (race, ethnicity, BMI) with other participants; race/ethnicity by self-identification (WHO and national census categories); BMI per WHO categories.
  • Cancer diagnosis confirmed within 90 days prior to sample collection.
  • Biopsy-proven malignancy with radiological staging.
Show all 13Show fewer
  • No anticancer treatment at the time of collection or within the previous 3 years.
  • No cancer diagnosis or treatment in the previous 3 years (ICD-O-3 behavior code 2 or 3).
  • Not under evaluation for suspected cancer (verified by medical record review or additional medical evaluation).
  • Subjects with benign tumors (code 0) or tumors of uncertain behavior (code 1) may be included if there is no clinical evidence of progression or malignancy.
  • Additional criteria - tumor-burden monitoring (Sub-study 2b):
  • Biopsy-confirmed cancer.
  • ECOG performance status ≤ 2.

Who cannot join

  • Failure to meet the general or cohort-specific inclusion criteria.
  • Pregnancy.
  • Organ transplant recipients.
  • Use of demethylating agents (azacitidine, decitabine) or cytotoxic agents (including for autoimmune/inflammatory conditions).
  • Prior or ongoing anticancer therapy: cancer surgery beyond that needed for diagnosis; local, regional, or systemic chemotherapy (including chemoembolization); targeted therapy; immunotherapy (including cancer vaccines); hormonal therapy; or radiotherapy.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Andrés Cardona, MD, MSc, PhD, MBA contact

+573016348173

acardona@fctic.org

Colombia1 site, 1 recruiting

  • Fundación CTIC Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo

    Bogotá, Bogota D.C., 110131

    Liliana Gutiérrez Babativa, RN, MSc, +573003768158, lgutierrez@fctic.org

    Recruiting

Other trials in Colombia

About this study

Official title: Evaluation of a Rapid Test for the Detection of Methylation Profiles (Methylscape) in Various Body Fluids as a Universal Biomarker for Cancer Detection and Monitoring

DNA methylation changes occur early and broadly during carcinogenesis. Methylscape is a rapid assay that detects global DNA methylation patterns in body fluids (blood, urine, and saliva) and may detect a cancer signal and predict the cancer signal origin (CSO) from a single fluid sample, using the differential interaction between methylated and unmethylated DNA and gold nanoparticles.

This prospective observational study evaluates the diagnostic performance (sensitivity and specificity) of the Methylscape test in Colombian patients with various biopsy-confirmed solid tumors compared with age- and sex-matched cancer-free (healthy) volunteers. The study is conducted in three parts: Phase 1 validates the assay in 250 patients with cancer; Sub-study 2a compares 1,500 patients with cancer against 1,500 matched cancer-free volunteers; and Sub-study 2b uses serial blood and urine sampling in 300 patients with early-stage disease to assess detection of disease relapse during follow-up, in parallel with standard imaging.

The study also estimates positive and negative predictive values (PPV/NPV) and projects the budget impact and cost-effectiveness of Methylscape as a multi-cancer early detection (MCED) tool in an upper-middle-income Latin American setting.

Read the detailed description

Background. Most cancers lack reliable screening methods, often leading to advanced-stage diagnosis. Multi-cancer early detection (MCED) tests based on body fluids can screen for several cancer types from a single sample. DNA methylation, which occurs early in carcinogenesis and is tissue-specific, is the most commonly used marker in MCED assays. Methylscape leverages global differences in the genomic distribution of methylation between cancerous and normal tissues, detected electrochemically through differential adsorption of DNA on gold electrodes.

Objective. To determine whether Methylscape can detect the methylation landscape across multiple cancer types with sufficiently high specificity to predict the cancer signal origin (CSO), and to assess its potential application as a population-scale MCED test among Colombians.

Design. Single-center prospective observational study conducted at CTIC (Bogotá, Colombia), with sample processing at CTIC and Columbia University. Phase 1 (N=250 patients with cancer) provides initial validation across solid tumor types selected by local incidence. Sub-study 2a (1,500 patients with cancer and 1,500 matched cancer-free volunteers) provides large-scale clinical validation. Sub-study 2b (N=300 early-stage patients) evaluates serial blood/urine Methylscape testing for relapse detection during follow-up every 6 months. Phase 1 participants may enter Sub-studies 2a/2b only if they meet the corresponding criteria and provide new informed consent; cross-phase participation is flagged in the database to adjust statistical estimates.

Biospecimens \& reference standards. Blood/plasma (K2EDTA), urine, saliva, and FFPE tumor tissue are collected and stored at -80 °C in the CTIC biobank. Cancers are coded with WHO ICD-O-3; stage per AJCC 8th edition. Reference standards: histopathology (MCED), RECIST 1.1 or biopsy (relapse), and absence of cancer by record review plus 12-month follow-up (cancer-free).

Statistical analysis. Sensitivity and specificity are estimated overall and by stage/type (expected sensitivity 85-90%, specificity 98%; 95% confidence, 80% power). PPV/NPV are derived via Bayes' theorem with prevalence from GLOBOCAN 2022; 95% CIs by stratified bootstrap (1,000 resamples). Budget impact and cost-effectiveness (QALYs) are projected via microsimulation and Markov models.

Being tested
Methylscape DNA methylation assay
Keywords
DNA methylation, Liquid biopsy, Cell-free DNA (cfDNA), Multi-cancer early detection (MCED), Methylscape, Cancer signal origin, Minimal residual disease, Methylation biomarker, Cancer screening, Colombia
Medical subject headings
Neoplasms, Breast Neoplasms, Lung Neoplasms, Stomach Neoplasms, Uterine Cervical Neoplasms, Colorectal Neoplasms, Urologic Neoplasms, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Methylscape DNA methylation assayDiagnostic test

    Rapid assay measuring global DNA methylation patterns in body fluids (blood/plasma, urine, saliva) and FFPE tumor tissue via differential adsorption of methylated vs. unmethylated DNA on gold electrodes (differential pulse voltammetry), to detect a cancer signal and predict the cancer signal origin (CSO). Applied to both groups; no therapeutic intervention is administered.

Study groups in NCT07741435
Study groupRoleWhat they receive
Patients with cancerColombian adults (≥18 y) with biopsy-confirmed solid tumors (behavior code 3, ICD-O-3) diagnosed within 90 days and untreated. Provide blood, urine, saliva, and FFPE tumor tissue for Methylscape testing. An early-stage subset is followed with serial blood/urine sampling for relapse detection (Sub-study 2b).
Receives: Diagnostic Test: Methylscape DNA methylation assay
Cancer-free (healthy) volunteersColombian adults (≥18 y) without cancer diagnosis or treatment in the prior 3 years, matched to cancer patients by sex, age, race/ethnicity, and BMI. Provide blood, urine, and saliva for Methylscape testing (Sub-study 2a).
Receives: Diagnostic Test: Methylscape DNA methylation assay

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitivity of the Methylscape test for cancer-signal detection, as assessed against histopathological confirmation as the reference standard

    Percentage of participants with biopsy-confirmed cancer who have a positive Methylscape result (cancer signal detected). Reported overall and by subgroup (cancer stage per AJCC 8th ed. and cancer type per ICD-O); all subgroups use the same unit. Adjusted by GLOBOCAN 2022 incidence.

    Measured: Baseline

  2. Specificity of the Methylscape test for cancer-signal detection, as assessed against absence of cancer confirmed by medical-record review and 12-month follow-up

    Percentage of confirmed cancer-free volunteers who have a negative Methylscape result (no cancer signal detected).

    Measured: 12 months

Secondary outcomes (2)

  1. Accuracy of Methylscape cancer-signal-origin (CSO) prediction, measured as the percentage of cases in which the predicted tissue of origin matches the histopathologically confirmed primary tumor site

    Among participants with a positive Methylscape cancer signal, the percentage in which the Methylscape-predicted tissue of origin agrees with the confirmed primary site (ICD-O morphology code).

    Measured: Baseline

  2. Sensitivity and specificity of serial Methylscape testing for detection of disease relapse, as assessed against imaging response (RECIST 1.1) or biopsy of local recurrence

    In early-stage participants under follow-up (Sub-study 2b), sensitivity and specificity of serial blood/urine Methylscape testing for detecting disease relapse. Sensitivity and specificity are both reported as percentages (same unit of measure); the reference standard is radiological progression per RECIST 1.1 or biopsy-confirmed local recurrence.

    Measured: At 6, 12, 18, and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2026
  2. Study start5 Jun 2025
  3. Primary completion4 Jun 2027 (estimated)
  4. Study completion15 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
3,250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07741435
Sponsor's protocol ID
Methylscape
Other IDs
CEI-183
Acronym
METHYLSCAPE-CO
Status last verified
Jul 2026
First submitted
23 Jun 2026
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) underlying the results reported in study publications will be made available, together with the corresponding data dictionary. Data will be shared in fully anonymized form, with direct and indirect identifiers removed in accordance with Colombian Law 1581 of 2012 on personal data protection. Sharing is subject to the approvals and conditions described under Access Criteria and to any constraints arising from the sponsor's intellectual-property rights in the Methylscape assay

Publications

  • Sina AA, Carrascosa LG, Liang Z, Grewal YS, Wardiana A, Shiddiky MJA, Gardiner RA, Samaratunga H, Gandhi MK, Scott RJ, Korbie D, Trau M. Epigenetically reprogrammed methylation landscape drives the DNA self-assembly and serves as a universal cancer biomarker. Nat Commun. 2018 Dec 4;9(1):4915. doi: 10.1038/s41467-018-07214-w.

    PubMed 30514834

  • Bretthauer M, Wieszczy P, Loberg M, Kaminski MF, Werner TF, Helsingen LM, Mori Y, Holme O, Adami HO, Kalager M. Estimated Lifetime Gained With Cancer Screening Tests: A Meta-Analysis of Randomized Clinical Trials. JAMA Intern Med. 2023 Nov 1;183(11):1196-1203. doi: 10.1001/jamainternmed.2023.3798.

    PubMed 37639247

  • Welch HG, Bergmark R. Cancer Screening, Incidental Detection, and Overdiagnosis. Clin Chem. 2024 Jan 4;70(1):179-189. doi: 10.1093/clinchem/hvad127.

    PubMed 37757858

  • Tafazzoli A, Ramsey SD, Shaul A, Chavan A, Ye W, Kansal AR, Ofman J, Fendrick AM. The Potential Value-Based Price of a Multi-Cancer Early Detection Genomic Blood Test to Complement Current Single Cancer Screening in the USA. Pharmacoeconomics. 2022 Nov;40(11):1107-1117. doi: 10.1007/s40273-022-01181-3. Epub 2022 Aug 30.

    PubMed 36038710

  • Nicholson BD, Oke J, Virdee PS, Harris DA, O'Doherty C, Park JE, Hamady Z, Sehgal V, Millar A, Medley L, Tonner S, Vargova M, Engonidou L, Riahi K, Luan Y, Hiom S, Kumar H, Nandani H, Kurtzman KN, Yu LM, Freestone C, Pearson S, Hobbs FR, Perera R, Middleton MR. Multi-cancer early detection test in symptomatic patients referred for cancer investigation in England and Wales (SYMPLIFY): a large-scale, observational cohort study. Lancet Oncol. 2023 Jul;24(7):733-743. doi: 10.1016/S1470-2045(23)00277-2. Epub 2023 Jun 20.

    PubMed 37352875

  • Minasian LM, Pinsky P, Katki HA, Dickherber T, Han PKJ, Harris L, Patriotis C, Srivastava S, Weil CJ, Prorok PC, Castle PE. Study design considerations for trials to evaluate multicancer early detection assays for clinical utility. J Natl Cancer Inst. 2023 Mar 9;115(3):250-257. doi: 10.1093/jnci/djac218.

    PubMed 36458902

  • Klein EA, Richards D, Cohn A, Tummala M, Lapham R, Cosgrove D, Chung G, Clement J, Gao J, Hunkapiller N, Jamshidi A, Kurtzman KN, Seiden MV, Swanton C, Liu MC. Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set. Ann Oncol. 2021 Sep;32(9):1167-1177. doi: 10.1016/j.annonc.2021.05.806. Epub 2021 Jun 24.

    PubMed 34176681

  • LeeVan E, Pinsky P. Predictive Performance of Cell-Free Nucleic Acid-Based Multi-Cancer Early Detection Tests: A Systematic Review. Clin Chem. 2024 Jan 4;70(1):90-101. doi: 10.1093/clinchem/hvad134.

    PubMed 37791504

  • Cohen JD, Li L, Wang Y, Thoburn C, Afsari B, Danilova L, Douville C, Javed AA, Wong F, Mattox A, Hruban RH, Wolfgang CL, Goggins MG, Dal Molin M, Wang TL, Roden R, Klein AP, Ptak J, Dobbyn L, Schaefer J, Silliman N, Popoli M, Vogelstein JT, Browne JD, Schoen RE, Brand RE, Tie J, Gibbs P, Wong HL, Mansfield AS, Jen J, Hanash SM, Falconi M, Allen PJ, Zhou S, Bettegowda C, Diaz LA Jr, Tomasetti C, Kinzler KW, Vogelstein B, Lennon AM, Papadopoulos N. Detection and localization of surgically resectable cancers with a multi-analyte blood test. Science. 2018 Feb 23;359(6378):926-930. doi: 10.1126/science.aar3247. Epub 2018 Jan 18.

    PubMed 29348365

  • Hackshaw A, Clarke CA, Hartman AR. New genomic technologies for multi-cancer early detection: Rethinking the scope of cancer screening. Cancer Cell. 2022 Feb 14;40(2):109-113. doi: 10.1016/j.ccell.2022.01.012. Epub 2022 Feb 3.

    PubMed 35120599

  • Smith RA, Andrews KS, Brooks D, Fedewa SA, Manassaram-Baptiste D, Saslow D, Wender RC. Cancer screening in the United States, 2019: A review of current American Cancer Society guidelines and current issues in cancer screening. CA Cancer J Clin. 2019 May;69(3):184-210. doi: 10.3322/caac.21557. Epub 2019 Mar 15.

    PubMed 30875085

Questions about this trial

What is this clinical trial studying?

An observational study of Neoplasms and Solid Tumor, run by Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo at 1 site in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrés Cardona, MD, MSc, PhD, MBA (+573016348173, acardona@fctic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity of the Methylscape test for cancer-signal detection, as assessed against histopathological confirmation as the reference standard (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07741435, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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